Useful Advices - Business

In a village, there was a slaughterhouse, its owner, butchers and m

According to USFDA, a combination product is one composed of any combination of a drug and device; biological product and device; drug and biological product

any goats. As time passed the number of goats increased in the slau

; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

Examples of combination products may in

hterhouse but number of butchers was same.

The owner thought inste

lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

ad of looking for new butchers, lets make one of the goat a butcher

here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe

He had a doubt in his mind that a goat might not fit into butchers

d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

Combination pro

role, but then he thought "Lets take a chance and see how it goes.

ucts have become life saving products for the pharmaceutical companies who doesn’t have many innovative molecules in their product pipeline and have been inc

If this experiment succeeds I can make other goats a butcher."

The

easingly used in the product life cycle management. Even the companies having product patents are trying to extend their product life cycle through the combi

owner picked one wise goat and told him, "I want to make you a butc

nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically

her, are you ready for this?". Wise goat thought this is a good op

and physically. They need to rightly judge the benefits of the combination products and they have to even look at the risks involved when combining the produ

ortunity and said, "Yes."

Next day the Wise goat came dressed like

ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi

a butcher. As per rotation policy, it was turn of a goat who was th

ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

Following aspects would a

e best friend of the wise goat to get slaughtered. The wise goat gr

dd to the challenges in developing combination products:

Which markets to tap where the combination products can do fairly well?
Which combination prod

bbed his best friend with a knife in hand.

All other goats cried,

cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin

"Wise goat, you are one of us, how can you do this. Don't you have

tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen

ny ethics?"

"I am a butcher now, and to slaughter goats is

t?

As combination products don't fit into the traditional categories of drugs, medical devices, or biological products, the USFDA is in the process of devel

my role. When I have a role to play I don't care about ethics and

ping new procedures for reviewing their safety, efficacy and quality.

Professional from academic institutions, pharmaceutical industries, health care indust

motions.", wise goat replied and slaughtered his friend.

y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products

believe if you are a faint hearted goat, don't become a butcher. O

.

As there is an increasing trend of the combination products companies manufacturing such products should be able to tackle the problems involved in the de

nce you become butcher be ready to slaughter any goat.

If

elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

Companies that provide selfless information through particip

ou were in place of the wise goat what would have you done?

tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products

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Useful Advices - Slaughterhouse Ethics

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